Navigating Regulatory Landmines for Combination Products – MedTech CRO: Regulatory Expertise Series

Device Advice by RQM+

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠⁠⁠⁠⁠⁠⁠⁠⁠reach out to RQM+⁠⁠⁠⁠⁠⁠⁠⁠⁠ if you need support with clinical trials.*

While she has moved towards retirement since recording this video with Jaishankar Kutty, Ph.D., Nancy Morrison, RAC talks about the regulatory landmines around 𝗰𝗼𝗺𝗯𝗶𝗻𝗮𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 in the newest video in our clinical trials series.

𝗪𝗮𝘁𝗰𝗵 𝗳𝗼𝗿 𝗶𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗼𝗻:

◽ Determining the regulatory pathway for your combination product

◾ Addressing regulators' primary concerns in submissions

◽ Overcoming clinical trial challenges unique to combination products

◾ Key learnings from real-world cases

Whether developing drug-device combinations, drug-eluting implants, or other innovative combination products, this video offers guidance to help avoid costly delays and regulatory pitfalls.

If you're interested in RQM+ helping you strategically approach combination product development and set your product up for regulatory success, let us know. 📞

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